Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity

Endometrial Cancer Clinical Trial

Official title:

Is Pipelle Biopsy of Benefit in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05378152
• Other study ID #: REC-2021-025
• Status: Completed
• Phase: N/A
• Start date: September 24, 2022
• Est. completion date: February 25, 2024

Study information

• Verified date: April 2024
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postmenopausal bleeding (PMB) is the occurrence of vaginal bleeding 12 months following a woman's last menstrual cycle. PMB represents one of the most common reasons for referral to gynaecology services. Approximately 10% of women with PMB will be found to have endometrial cancer. The gold standard of investigation of PMB is ambulatory gynaecology through the outpatient hysteroscopy clinic, which is often combined with Pipelle biopsy for endometrial sampling.

Up to 60% of women that present with PMB will have an atrophic-appearing cavity at hysteroscopy. This provides a challenge in obtaining a histological sample through both dilatation & curretage (D&C) and Pipelle biopsy. Often, scant tissue that is insufficient for clinical diagnosis is obtained.

Pipelle biopsy is associated with patient discomfort. It is also associated with costs related to the purchasing of equipment and the processing of samples in the laboratory to the sum of approximately 30 euro per sample. It is rare that a sample taken from an atrophic cavity will return any clinically meaningful result. A negative hysteroscopy reduces the probability of endometrial cancer to 0.6%.

This study aims to compare patients with PMB and atrophic-appearing cavity that undergo pipelle biopsy to those that do not. Differences in pain scores, cost saving and differences in clinical follow up will be assessed to evaluate the benefit of Pipelle biopsy in patients with PMB and atrophic-appearing cavity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 25, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal

• Postmenopausal bleeding

• Tolerates hysteroscopy

Exclusion Criteria:

• Premenopausal

• Any lesion requiring biopsy at time of hysteroscopy

• Obvious cause of bleeding from the vagina or cervix at time of hysteroscopy

• History of endometrial hyperplasia/cancer

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hemorrhage
• Hyperplasia
• Postmenopausal Bleeding
• Uterine Hemorrhage

Intervention

Device:
• Pipelle biopsy catheter
A speculum will be inserted into the vagina. A Pipelle biopsy catheter will be inserted through the cervix up to the fundus of the uterus. The internal piston will be withdrawn to create negative pressure. The catheter will be moved back and forth and rotated to collect the biopsy. The catheter will then be removed, followed by the speculum. The sample will be sent to the laboratory for assessment.
• Sham procedure
A speculum is inserted into the vagina and then removed

Locations

Country	Name	City	State
Ireland	Rotunda hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland	The Rotunda Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain	Immediately before procedure, less than 5 minutes prior to starting hysteroscopy
Primary	Pain scores	Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain	Immediately after procedure, within 1 minute of finishing hysteroscopy
Primary	Pain scores	Pain scores between groups using a 100mm visual analogue pain scale, with 100mm representing the highest level of pain	Immediately after intervention, within 1 minute of carrying out intervention
Secondary	Cost saving	Cost saving between the two groups	3 months
Secondary	Changes in follow up	Changes in follow up between groups including the number of repeat OPH assessments, follow up visits, repeat ultrasound scans and other related hospital attendances.,	3 months